Growth Hormone Deficiency (GHD)Phase 3NCT07553351
GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
A Phase 3 study testing GB06 and Norditropin®FlexProTM in people with Growth Hormone Deficiency (GHD) and Growth Hormone Deficiency in Children, run by Kexing Biopharm Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- What is being tested?
- GB06 and Norditropin®FlexProTM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to 24 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.
- Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
- Height below two standard deviations (SD) of the average height of children of the same age and gender;
- Annual height velocity (AHV) <5cm/year, based on height within 6 months to 18 months before screening;
- Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
- Short stature with normal intellectual development;
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- Tanner stage I (testicular volume <4ml for boys, no palpable breast gland tissue for girls);
- IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;
- Bone age lags behind the chronological age;
- Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng/ml;
- A standard karyotype of 46, XX for girls.
Who cannot join
- Known allergy to ingredients of the study drug;
- Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
- Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
- Small for gestational age;
- Epiphyseal closure;
- Congenital intracranial hypertension;
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- Slipped capital femoral epiphysis;
- GHD secondary to another pituitary hormone deficiency;
- Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;
- History of fundus lesions (optic nerve papilledema lesions);
- Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol/L or hemoglobin A1c (HbA1c) ≥ 6.5%;
- Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;
- Expected requirement to inhale budesonide >400μg/day or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;
- Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene abnormality, GH receptor deletion, or other significant genetic mutations causing short stature; Significant spinal abnormalities, including but not limited to scoliosis, kyphosis, and spina bifida; Congenital anomalies (resulting in skeletal abnormalities), including but not limited to Russell-Silver syndrome and bone dysplasia; Family history of bone dysplasia;
- Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction [e.g., alanine aminotransferase (ALT)> 1.5 times the upper limit of normal, creatinine (Cr) >upper limit of normal value], malnutrition, severe cardiopulmonary and hematological diseases, systemic infection, immunodeficiency, mental abnormalities, and other congenital malformations;
- Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, and tuberculosis. Hepatitis B virus DNA levels will be assessed in individuals who are positive for HBV surface antigen.
- A hepatitis C virus RNA test is required if the hepatitis C virus antibody test is positive. Quantitative results below the lower limit of detection will be excluded.
- Concomitant use of other treatments that may affect growth, including but not limited to methylphenidate for attention deficit hyperactivity disorder;
- History of drug or alcohol abuse;
- Children with hypothyroidism and/or adrenal insufficiency who have not received adequate stable replacement therapy lasting at least 90 days before randomization;
- Other diseases that the investigator believes may endanger the safety of the participant or protocol compliance;
- Potentially poor compliance in this study.
- Other conditions that the investigator deems unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chengdu Women and Children Central Hospital
Chengdu, Sichuan, 610074
Prof. Cheng, +86 028-63806390, cheng_xr23@outlook.com
About this study
Official title: A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Trial to Study the Efficacy and Safety of Human Growth Hormone Injection (GB06) in Treating Growth Disorders Caused by Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.
Read the detailed description
Growth hormone deficiency (GHD) in children is characterized by short stature with a low annual height growth rate. GHD also alters body composition, including loss of lean body mass, increased abdominal visceral fat deposition, and a higher waist-to-hip ratio. Patients with GHD may also have hyperlipidemia and atherosclerosis, left ventricular dysfunction, hypertension, and elevated plasma fibrinogen levels, leading to increased cardiovascular and cerebrovascular risk. In addition, GHD can also affect cognitive function and overall well-being. These patients are also more likely to experience low energy, difficulty in concentration, social isolation, and depression.
Growth hormone (GH) supplementation is the ideal treatment for patients with GHD, and the above-mentioned abnormalities can also be improved after GH therapy. Recombinant human GH has been approved for the treatment of GHD and used for more than 30 years with favorable efficacy and safety. GB06, developed by Kexing Biopharm Co., Ltd., is a biosimilar of Norditropin®FlexProTM. Its effectiveness and safety have been verified in phase I clinical studies. This study aims to further assess the comparability of the efficacy and safety of GB06 and Norditropin®FlexProTM in pediatric patients with GHD.
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Being tested
- GB06, Norditropin®FlexProTM
- Keywords
- Growth Hormone, Growth Hormone Deficiency, Annual Height Velocity, Insulin-like Growth Factor-1, Bone Age, GB06
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB06Drug
GB06 0.035mg/kg/day by subcutaneous injection for 52 weeks
Norditropin®FlexProTMDrug
Norditropin®FlexProTM 0.035mg/kg/day by subcutaneous injection for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| GB06 | Experimental | Not described Receives: Drug: GB06 |
| Norditropin®FlexProTM | Active comparator | Not described Receives: Drug: Norditropin®FlexProTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual height velocity (AHV) at week 52.
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (10)
AHV at weeks 5, 13, 26, and 39 and their changes from baseline
Measured: From enrollment to treatment at 39 weeks
AHV standard deviation score (SDS) at weeks 5, 13, 26, 39, and 52, and their change from baseline
Measured: From enrollment to the end of treatment at 52 weeks
Change in height SDS for chronological age (Ht SDS CA) at weeks 5, 13, 26, 39, and 52, and comparison with baseline
Measured: From enrollment to the end of treatment at 52 weeks
Bone age at week 52
Bone age at week 52 will be compared with that from baseline
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline in Bone Age Height SDS (Ht SDS BA) at Week 52
Measured: From enrollment to the end of treatment at 52 weeks
Tanner stage at weeks 26 and 52 and changes from baseline
Measured: From enrollment to the end of treatment at 52 weeks
IGF-1 and IGF-1 SDS at weeks 5, 13, 26, 39, and 52
Measured: From enrollment to the end of treatment at 52 weeks
IGFBP-3 and IGFBP-3 SDS at weeks 5, 13, 26, 39, and 52
Measured: From enrollment to the end of treatment at 52 weeks
Incidence of Anti-drug antibodies (ADAs) and neutralizing antibodies (Nab) at baseline and weeks 5, 13, 26, 39, 52
Measured: From enrollment to the end of treatment at 52 weeks
The incidence of adverse events
Measured: From enrollment to 56 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start6 Jun 2026
- Primary completion25 Jul 2028 (estimated)
- Study completion24 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone Deficiency (GHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexing Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553351
- Sponsor's protocol ID
- KXZY-GB06-301
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Trial to Study the Efficacy and Safety of Human Growth Hormone Injection (GB06) in Treating Growth Disorders Caused by Pediatric Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT07553351
- Acronym / sponsor ID
- KXZY-GB06-301
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Keywords
- Growth Hormone, Growth Hormone Deficiency, Annual Height Velocity, Insulin-like Growth Factor-1, Bone Age, GB06
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Kexing Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2026 (actual)
- Primary completion
- 25 Jul 2028 (estimated)
- Study completion
- 24 Oct 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.
Detailed description
Growth hormone deficiency (GHD) in children is characterized by short stature with a low annual height growth rate. GHD also alters body composition, including loss of lean body mass, increased abdominal visceral fat deposition, and a higher waist-to-hip ratio. Patients with GHD may also have hyperlipidemia and atherosclerosis, left ventricular dysfunction, hypertension, and elevated plasma fibrinogen levels, leading to increased cardiovascular and cerebrovascular risk. In addition, GHD can also affect cognitive function and overall well-being. These patients are also more likely to experience low energy, difficulty in concentration, social isolation, and depression.
Growth hormone (GH) supplementation is the ideal treatment for patients with GHD, and the above-mentioned abnormalities can also be improved after GH therapy. Recombinant human GH has been approved for the treatment of GHD and used for more than 30 years with favorable efficacy and safety. GB06, developed by Kexing Biopharm Co., Ltd., is a biosimilar of Norditropin®FlexProTM. Its effectiveness and safety have been verified in phase I clinical studies. This study aims to further assess the comparability of the efficacy and safety of GB06 and Norditropin®FlexProTM in pediatric patients with GHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB06 | Experimental | Drug: GB06 |
| Norditropin®FlexProTM | Active comparator | Drug: Norditropin®FlexProTM |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.
- Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
- Height below two standard deviations (SD) of the average height of children of the same age and gender;
- Annual height velocity (AHV) <5cm/year, based on height within 6 months to 18 months before screening;
- Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
Key exclusion criteria (23 listed)
- Known allergy to ingredients of the study drug;
- Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
- Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
- Small for gestational age;
- Epiphyseal closure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB06GB06 0.035mg/kg/day by subcutaneous injection for 52 weeks | Drug | GB06 |
| Norditropin®FlexProTMNorditropin®FlexProTM 0.035mg/kg/day by subcutaneous injection for 52 weeks | Drug | Norditropin®FlexProTM |
Primary outcome
Annual height velocity (AHV) at week 52.
Time frame: From enrollment to the end of treatment at 52 weeks
10 secondary outcomes
AHV at weeks 5, 13, 26, and 39 and their changes from baseline
Time frame: From enrollment to treatment at 39 weeks
AHV standard deviation score (SDS) at weeks 5, 13, 26, 39, and 52, and their change from baseline
Time frame: From enrollment to the end of treatment at 52 weeks
Change in height SDS for chronological age (Ht SDS CA) at weeks 5, 13, 26, 39, and 52, and comparison with baseline
Time frame: From enrollment to the end of treatment at 52 weeks
Bone age at week 52
Time frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in Bone Age Height SDS (Ht SDS BA) at Week 52
Time frame: From enrollment to the end of treatment at 52 weeks
Tanner stage at weeks 26 and 52 and changes from baseline
Time frame: From enrollment to the end of treatment at 52 weeks
IGF-1 and IGF-1 SDS at weeks 5, 13, 26, 39, and 52
Time frame: From enrollment to the end of treatment at 52 weeks
IGFBP-3 and IGFBP-3 SDS at weeks 5, 13, 26, 39, and 52
Time frame: From enrollment to the end of treatment at 52 weeks
Incidence of Anti-drug antibodies (ADAs) and neutralizing antibodies (Nab) at baseline and weeks 5, 13, 26, 39, 52
Time frame: From enrollment to the end of treatment at 52 weeks
The incidence of adverse events
Time frame: From enrollment to 56 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB06 and Norditropin®FlexProTM in people with Growth Hormone Deficiency (GHD) and Growth Hormone Deficiency in Children, run by Kexing Biopharm Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual height velocity (AHV) at week 52. (time frame: From enrollment to the end of treatment at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.